In this article, David Roderick discusses (a) the recent case of Negus v Guy’s and St Thomas’ NHS Foundation Trust  EWHC 643 (QB); (b) relevant criteria for assessing the adequacy of information and/or consent illustrated by the reported cases since Montgomery v Lanarkshire Health Board  UKSC 11, and (c) the new General Medical Council guidance to doctors on decision making and consent.
To what degree should an advice or consent discussion address the permutations of alternative treatments, the technical detail of variant treatments and their respective risks, and any contingencies arising during the course of treatment?
It is now uncontroversial that obtaining informed consent for a medical procedure requires a discussion between a doctor and patient of the material risks involved in the treatment; of the possible alternative or variant treatments, and the risks inherent in those alternatives. However, each such discussion will naturally be fact specific, and the extent of the information required so as to constitute adequately informed consent remains ripe for dispute.
In the recent case of Negus v Guy’s and St Thomas’ NHS Foundation Trust  EWHC 643 (QB) (19 March 2021), a claim was pursued on behalf of TN, in relation to aortic valve replacement surgery. In March 2014, TN underwent implantation of a 19mm mechanical valve. That implant proved insufficient, and resulted in a ‘patient-prosthesis mismatch’, a type of cardiac dysfunction. Therefore, in March 2015, TN underwent re-do surgery to insert a larger valve which required an aortic root enlargement procedure (“ARE”). Difficulties arose during this second operation, TN developed complications during post-operative recovery, and her condition then deteriorated leading to her death from heart failure in January 2020.
The Claimants’ case was that the first surgery in 2014 was negligent because a larger sized valve should have been implanted, even though that would have required an ARE. Further, and which is the focus of this article, that there had been a negligent failure to properly advise TN as to the risks arising from the implantation of a smaller valve, and a failure to advise as to the possibility of a larger valve and performing an ARE as a variant treatment. The Claimants’ contended that the re-do operation and TN’s subsequent deterioration and death would have been avoided had an ARE been performed on 5 March 2014 and a larger valve initially implanted. The agreed issues requiring determination were fourfold:
i) Was it negligent to implant a 19mm mechanical reduced valve during TN’s surgery on 5 March 2014?
ii) Alternatively, was there a negligent failure to explain, as part of the consent process, that the largest possible valve should be implanted to avoid the risk of cardiac dysfunction although this would involve an ARE, which was more complicated and involved higher risk? If so, would TN have opted to undergo ARE?
iii) If an attempt had been made to implant a larger valve, would TN have suffered the same complications that she did during surgery on 18 March 2015?
iv) Did the failure to implant a 21mm valve cause the cardiac dysfunction requiring re-do surgery on 18 March 2015, with associated complications, and TN’s subsequent death on 29 January 2020?
In relation to issue i) it was concluded, essentially on the assessment of the expert evidence, that the decision to initially implant a 19mm valve was a reasonable exercise of judgement. That was determined on an application of the well-known test that a medical practitioner is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art with the court being satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis Bolam v Friern Hospital Management Committee  1 W.L.R. 582 and Bolitho v City and Hackney Health Authority  AC 232.
For the purposes of this article therefore, issue ii) is obviously the most relevant. In relation to obtaining informed consent, different considerations of course apply, following Montgomery v Lanarkshire Health Board  UKSC 11. The arguably paternalistic former dynamic within the doctor/patient relationship has now shifted towards the enabling of patient autonomy. A patient is entitled to decide which, if any, of the available forms of treatment to undergo, and consent must be obtained before treatment is undertaken. The scope of this duty is to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.
The test of materiality in respect of risk is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it. Furthermore, the significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient (Montgomery, paragraphs 87 and 89).
Developments since Montgomery
Therefore, before turning to the assessment of the adequacy of the information and consent process in Negus, it is useful to outline the following decisions in respect of obtaining consent and/or the provision of information since Montgomery. The cases illustrate what adequately informed consent might or might not be:
Unsurprisingly perhaps, the cases do not result in a simple catalogue of generally applicable criteria suitable for every case crossing the clinical negligence lawyer’s desk. However, some particularly relevant factors can be identified:
GMC guidance on decision making and consent
Negus is also one of the first High Court cases on the scope of the content of advice and information since the General Medical Council’s new guidance document ‘Decision making and consent’ came into effect on 9 November 2020. The previous iteration of this advice pre-dated the decision in Montgomery.
The stated intention of the guidance is to help make sure that the doctor has obtained informed consent from the patient, and it expressly advises on ‘what you should tell a patient when talking about risks’. The guidance contains much extremely useful advice which can’t all be cited here; however the most germane points are as follows.
It is likely that the guidance will be a source of reference in future claims. It can be seen that the guidance reflects the outcome of the some of the cases discussed above: for example, the necessity to discuss even very unlikely risks if serious harm might eventuate, and the requirement to discuss benefits, risks and uncertainties for each available option. That language will be of assistance to a claimant trying to establish a claim for failed consent.
Conversely, the overriding element of professional discretion is maintained by the guidance which expressly validates a doctor exercising their own judgment about how to apply the guidance given the specific circumstances of each decision.
It is not apparent from the judgment in Negus whether the GMC guidance was referred to either in the expert reports or in argument.
The conclusion on information and consent in Negus
Returning to the operative question in Negus: was there a negligent failure to explain, as part of the consent process, that the largest possible valve should be implanted to avoid the risk of cardiac dysfunction even though this would involve an ARE? The material findings and conclusions reached by Mrs Justice Eady were that:
On those bases, Mrs Justice Eady concluded that the surgeon was under a limited duty to warn TN of the possible risk that he might need to undertake an ARE during the valve replacement operation (however, in that scenario, TN would likely have proceeded to surgery and thus causation was not made out). However, the duty did not extend to offering as a reasonable variant the possibility of undertaking an ARE to permit the insertion of a larger prosthetic valve, nor the various possible choices that might arise intra-operatively. This was because those choices involved highly technical decision-making, requiring a specialist-level of understanding and experience which most patients could not reasonably be expected to grasp, the choices would be made intra-operatively, and because it was not common practice amongst cardiothoracic surgeons to include the possibility of ARE when consenting patients.
The claim in Negus failed, and did not in fact benefit from TN’s past knowledge and experience as a nurse, nor her previous interaction engaging with the choice as to what type of valve to use, nor even the fact that the possibility of an ARE procedure had been in the surgeon’s mind prior to surgery. Nevertheless, following the Montgomery line of cases, Negus develops the important factors to look for in assessing whether reasonable alternatives have been adequately discussed:
David Roderick specialises in personal injury, clinical negligence, inquests and employment work, and their related procedural and costs issues. He acts on behalf of both claimants and defendants in serious injury cases, and predominantly on behalf of claimants in clinical negligence actions. Please contact the Clerks for further information.